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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Axle Interspinous Fusion System - M697X08033261308TSTRX1

IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 8°, 13mm (STERILE), CE MARKED
Xtant Medical Holdings, Inc.
X080-332613-08T-STRX
In Commercial Distribution

  • M697X08033261308TSTRX1 ()

  • Angle: 8 degree
  • Length: 26 Millimeter
  • Width: 33 Millimeter
  • Height: 13 Millimeter


  • Metallic spinal interbody fusion cage

Axle Interspinous Fusion System - M697X08033261308TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 8°, 13mm (STERILE)
Xtant Medical Holdings, Inc.
X080-332613-08T-STR
In Commercial Distribution

  • M697X08033261308TSTR1 ()

  • Width: 33 Millimeter
  • Height: 13 Millimeter
  • Angle: 8 degree
  • Length: 26 Millimeter


  • Metallic spinal interbody fusion cage

Axle Interspinous Fusion System - M697X08033261308TPCX1

IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 33 X 26 X 8°, 13mm, PC, CE MARKED
Xtant Medical Holdings, Inc.
X080-332613-08TPCX
In Commercial Distribution

  • M697X08033261308TPCX1 ()

  • Width: 33 Millimeter
  • Angle: 8 degree
  • Length: 26 Millimeter
  • Height: 13 Millimeter


  • Metallic spinal fusion cage, non-sterile

Axle Interspinous Fusion System - M697X08033261308TPCSTR1

IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 33 X 26 X 8°, 13mm, PC (STERILE)
Xtant Medical Holdings, Inc.
X080-332613-08TPC-STR
In Commercial Distribution

  • M697X08033261308TPCSTR1 ()

  • Width: 33 Millimeter
  • Height: 13 Millimeter
  • Angle: 8 degree
  • Length: 26 Millimeter


  • Metallic spinal interbody fusion cage

Axle Interspinous Fusion System - M697X08033261308TPC1

IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 33 X 26 X 8°, 13mm, PC
Xtant Medical Holdings, Inc.
X080-332613-08TPC
In Commercial Distribution

  • M697X08033261308TPC1 ()

  • Width: 33 Millimeter
  • Angle: 8 degree
  • Height: 13 Millimeter
  • Length: 26 Millimeter


  • Metallic spinal fusion cage, non-sterile

Axle Interspinous Fusion System - M697X08033261308T1

IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 8°, 13mm
Xtant Medical Holdings, Inc.
X080-332613-08T
In Commercial Distribution

  • M697X08033261308T1 ()

  • Angle: 8 degree
  • Height: 13 Millimeter
  • Width: 33 Millimeter
  • Length: 26 Millimeter


  • Metallic spinal fusion cage, non-sterile

Axle Interspinous Fusion System - M697X08033261308STRX1

IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 8°, 13mm (STERILE), CE MARKED
Xtant Medical Holdings, Inc.
X080-332613-08-STRX
In Commercial Distribution

  • M697X08033261308STRX1 ()

  • Angle: 8 degree
  • Length: 26 Millimeter
  • Height: 13 Millimeter
  • Width: 33 Millimeter


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697X08033261308STR1

IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 8°, 13mm (STERILE)
Xtant Medical Holdings, Inc.
X080-332613-08-STR
In Commercial Distribution

  • M697X08033261308STR1 ()

  • Length: 26 Millimeter
  • Angle: 8 degree
  • Width: 33 Millimeter
  • Height: 13 Millimeter


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697X08033261308PCX1

IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 8°, 13mm, PC, CE MARKED
Xtant Medical Holdings, Inc.
X080-332613-08PCX
In Commercial Distribution

  • M697X08033261308PCX1 ()

  • Width: 33 Millimeter
  • Height: 13 Millimeter
  • Length: 26 Millimeter
  • Angle: 8 degree


  • Polymeric spinal interbody fusion cage

Axle Interspinous Fusion System - M697X08033261308PCSTRX1

IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 8°, 13mm, PC (STERILE), CE MARKED
Xtant Medical Holdings, Inc.
X080-332613-08PC-STRX
In Commercial Distribution

  • M697X08033261308PCSTRX1 ()

  • Angle: 8 degree
  • Width: 33 Millimeter
  • Height: 13 Millimeter
  • Length: 26 Millimeter


  • Polymeric spinal fusion cage, sterile
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